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Automatic Nucleic Acid Detection Analyzer
EUDAMEDClass A (EU MDR)
Ref WO2050116Model Ideal 30Ref N/AModel Ideal 36
Identity
- Trade Name
- Automatic Nucleic Acid Detection Analyzer EUDAMED
- Device Name
- Automatic Nucleic Acid Detection Analyzer EUDAMED
- Model / Reference
- Ideal 30 EUDAMEDWO2050116 EUDAMEDIdeal 36 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975600660029 EUDAMED06975600660036 EUDAMED
- Basic UDI-DI
- 697560066Ideal30M3 EUDAMED697560066Ideal36MF EUDAMED
- Direct Marketing DI
- 06975600660029 EUDAMED06975600660036 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Detection Analyzer by Guangdong RunPon Bioscience Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid sample preparation instrument IVD.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697560066Ideal30M3 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangdong RunPon Bioscience Inc.
- EUDAMED SRN
- CN-MF-000025972
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED aab6e385-a5ee-41ba-b498-316c706831e2 61 fields · synced Jul 15, 2026
- EUDAMED d5507788-32bd-4838-a2ea-c4397530c665 61 fields · synced May 17, 2026